CN106132460A - There is the fluid delivery pen of the dosage setting feature of final dose stopping and improvement - Google Patents

Abstract

The fluid delivery pen of the present invention has the dosage setting friction mechanism of minimizing, this mechanism can using dosage set mechanism be to set corresponding each click with a unit dose to produce the sound of higher audibility, goes back each click when using dosage set mechanism is to reduce the dosage set and produces the sound of the audibility lower than the former.The fluid delivery pen drive mechanism of the present invention has the instruction that the fluid dosage in perfusion device terminates.

Description

Fluid delivery pen with final dose stop and improved dose setting features

technical field

The present invention relates to disposable fluid delivery pens for delivering fluids into the human body on demand. In particular, the present invention relates to devices for delivering fluids into a patient. These devices are disposable multi-dose delivery devices in which a pre-selected amount of fluid can be delivered to a patient. The fluid delivery pen includes a dose setting mechanism and a drive mechanism. The fluid delivery pen of the present invention has a reduced dose setting friction mechanism that can produce a higher audible sound for each click corresponding to a unit dose set using the dose setting mechanism, also for when the dose setting mechanism is set. Each click when the dose is reduced using the dose setting mechanism produces a less audible sound than the former. The fluid delivery pen drive mechanism of the present invention indicates the end of a dose of fluid in the cartridge. The end-of-dose mechanism of the present invention in a disposable fluid delivery pen does not use rotatable parts or a separate movable, non-rotating member with threaded features. The device of the present invention has the general shape and appearance of a pen and is therefore described as a fluid delivery pen.

Background technique

Pen-type drug delivery devices are used where routine injections by persons without formal pharmacy training occur. This is increasingly common among patients with diabetes where self-injection is effective in managing their disease.

In certain types of prior art drug delivery devices, such as fluid delivery pen-type devices, a cartridge for the drug is used. The medicament fluid used in the fluid delivery pen can be related to the insulin regimen, which is patient-specific and depends on the type of insulin to be injected (slow-acting, intermediate-acting, fast-acting, or a specific combination thereof), the patient's lifestyle, environment, the actual medical condition of the patient, etc.

Prior art fluid delivery pens disclose a piston rod or plunger rod whose engagement with a cartridge stopper facilitates the discharge of medicament in its forward direction of travel due to movement of the piston rod or plunger rod under applied force. There are many advantages to prior art fluid delivery pen devices having an internally threaded hollow piston rod, described in US Patent 7,771,398 and incorporated herein by reference. A piston rod with an internal non-locking helical thread could be substantially larger in diameter and would have a structurally effective hollow cross-section making it substantially stronger than a profile equivalent externally threaded rod. Also, the injection device has a direct mechanical drive between the person applying the injection force and the hollow piston rod which is driven forward to inject the medicament. This ensures that the person is aware of any problems in dose delivery. The dose setting means as disclosed in (US'398) uses a bi-directional ratchet which produces a tactile and audible click when the outer dose knob is rotated to set the dose. The audible click in the audible representation of dose setting (US '398) is consistent and the same when the dose is set and when the set dose is reduced.

Also, prior art hollow piston rod disposable fluid delivery pens are relatively large in size. Furthermore, the distal edge of the inner housing and the proximal edge of the fluid cartridge holder or cartridge cover are chemically or ultrasonically bonded. Prior art hollow piston rod pen devices may have an external cap or cap orientation that may not only be unsightly but snaps weakly over the features of the fluid cartridge holder resulting in improper protection of the internal components . There may not be any audible click when the dose dial returns to "0". The short length and shape of the finger pad/dose button can lead to incorrect dose delivery.

Where the patient is elderly, infirm or physically impaired, or has hearing impairment, the only other way to recognize or identify the dose setting is through the visual indication through the magnifying lens, the number displayed on the dose setting member. The prior art determination of dose setting by visual indication through a magnifying lens is not as desired when the patient is also visually impaired. Therefore, there is a need to develop a mechanism that is identifiable by a change in the degree of the click when the dose setting or the set dose is changed or decreased, i.e. a preferred higher audibility when the dose is set and a relative higher audibility when the dose is decreased. Low audibility. This is especially true in the case of diabetics when the drug is insulin or an insulin analogue that needs to be self-administered precisely in small doses and over-frequently.

Also, prior art pen device dose setting clicks rely on non-directional ratchets or occasionally bi-directional ratchets which produce a consistent sound when the dose is set or reduced, or the dose is delivered, as described in US 20110034878. The closest prior art dose setting mechanisms are listed below.

In EP 608 343 a fluid delivery pen with a dose setting mechanism is described wherein the dose is set by rotating a button relative to the housing to set the dose. The button is coupled to the driver by a ratchet forming a non-directional coupling which sets the dose over the teeth of the ratchet during rotation of the button in one direction. In US 6.004.297 a detent mechanism working between the driver tube and the housing is disclosed for creating the click mechanism. In US 20090254047, a connector tube 80, a ratchet 100, a protrusion 83 and a track 101 combine to achieve a click. In US 20090299297, the barrier 10 is axially slidable in the housing 30 but is rotationally locked to the housing 30 by a protrusion 11 sliding in a track 31 . The flanges of the barrier teeth 12 on the proximal end of the barrier 10 interact with the corresponding flanges of the button teeth 2 arranged inside the button 1 . In US 20080287883, the barrier 60 is axially slidably mounted to the housing 10 . The barrier 60 is provided with protrusions 61 sliding in longitudinal rails 12 provided on the inner surface of the housing 10 . In US 20110034878, although the piston rod 307 moves axially to expel the set dose, the tip 327 of the click finger 326 passes over the teeth 395 of the piston rod 307 distributed between two consecutive larger teeth 396, thereby providing An auditory feedback mechanism that indicates to the user that the dose is changing with an audible click.

Friction reduction in all prior art injection pen devices occurs when the user presses a button (or injection button or dose button or finger pad, as they are known by various names), the force applied can be transferred to the front of the drive part. movement in both directions and causes friction reduction by creating a pivotal bearing between the two parts. One way to reduce the friction between two parts may be to minimize the surface area of interaction between the two objects, whereby the radius of the resulting friction force can be kept to a minimum.

First, these prior art fluid delivery pen devices disclose an externally threaded piston rod or plunger rod whose engagement with the stopper of the cartridge facilitates medicament due to movement of the piston rod or plunger rod under application of force. Emissions as it moves forward. Second, a finger pad connection for an injection pen device that minimizes the force with which the user most applies an injected dose requires rotation between the finger pad and the mating component (ie, the driver that mates with the finger pad) relative to each other. Some of the closest prior art finger pad connections for fluid delivery pen devices having a piston rod with an externally threaded mechanism are listed below.

EP 1003581 discloses an injection device comprising a graduated cylinder, a cannula and a button according to Figs. 15-16. The scale cylinder and sleeve rotate together and the button and sleeve rotate relative to each other. WO 2005/018721 discloses an injection device in which a button is formed with a hole containing a stem on a hub build-up. The button and stem are welded together such that the button and sleeve member are axially rotationally fixed to each other. US 20100145282 discloses an injection device in which at least one radial support between a button and a protrusion is formed in an upper region and a lower region.

Unlike prior art fluid delivery pen devices having an externally threaded rod, the user injected dose is achieved through the reduction in friction when the user presses on the finger pad in a prior art fluid delivery pen device having a hollow piston rod with internal helical threads. The minimum of force that has to be applied is still an unmet need as long as it is envisaged in the present invention to have firstly a dose end mechanism and secondly a variable audibility feature when setting the dose or reducing the higher set dose.

Accordingly, it is an object of the present invention to address various deficiencies in precise dose setting and reduced dose delivery for vision/hearing impaired patients by prior art disposable fluid delivery pen devices comprising internally helically threaded hollow piston rods.

Another object of the present invention is to include an end-of-dose mechanism in a disposable fluid delivery pen device comprising a hollow piston rod with an internal helical thread.

Furthermore, it is an object of the present invention to address the need to address the unmet need for friction reduction that reduces the force a user must exert to inject a dose in a disposable fluid delivery pen device having a hollow piston rod with an internal helical thread Minimal, it has a fluid end-of-dose mechanism and a variable audibility feature during dose setting or reducing a set dose.

It is also noted that with prior art fluid delivery pen devices after repeated self-administration of fluid, the fluid flows down the cartridge and the user may attempt to set a dose that exceeds the amount of medicament left in the cartridge. Also, in some other fluid delivery pen devices of higher precision, the drug delivery device may be designed not to allow the user to dial a dose greater than the amount of drug left in the cartridge. Fluid can be wasted in such fluid delivery pen devices. Therefore, it may be necessary to avoid wasting fluid in disposable fluid delivery pen devices, and to develop a mechanism in which not only the entire fluid in the cartridge can be delivered (the amount of fluid remaining in the cartridge is the same as the practically allowable minimum limit) and the dose setting mechanism may indicate the amount of fluid that had not been delivered when the last set dose was delivered. This may enable the user to set the dose and inject it from a new disposable fluid delivery pen device. For example, when the last set dose in the disposable delivery device may be 60 IU (International Units) of insulin, the amount of insulin left in the cartridge may be 50 IU, then the end-of-dose mechanism of the present invention may be used after delivering 50 IU of insulin 10 IU is displayed in the dose setting window, so the patient will still know that there are 10 IU left to be delivered.

The prior art of US20090275916 reports a drug delivery pen device last dose blocking mechanism or end of dose content mechanism.

The disclosures of US20080243087, US2010324494, US2009137964, US20080108953 and US0090240195 are incorporated herein by reference. These prior art devices necessarily have a piston or plunger rod provided with threads on its outer surface.

US20090275916 discloses a dosing mechanism for a medicament delivery device comprising a dose setting limiting mechanism having a dose limiting member. US20080243087 discloses an end-of-content mechanism that can be positioned within a space defined by an inner wall of a driver, wherein an outer surface of the driver can be directly coupled to an inner surface of a barrel scale of an injection device. US20100324494 discloses a dose setting mechanism comprising a rotatable shaft having a first pitch in a first part and a second pitch in a second part. US 20090137964 discloses an injection device comprising a track coupled to one of a housing and a dose setting member. US20080108953 discloses an injection device comprising a different threaded rod and an internal thread comprising several contact surfaces. US20090240195 discloses a lock for an injection device comprising a threaded rod, wherein the lock comprises one of an anti-rotation element and a claw type fastening element.

It can be observed that all prior art fluid delivery pen devices having an end-of-content mechanism thereon include an externally threaded plunger or piston rod which engages the stopper of the cartridge used to dispense the medicament. It can also be observed that the above prior art devices use existing rotatable or movable members or separate parts for implementing the last dose lockout mechanism. For example, dose limiting member in US20090275916, limiter coupled to driver in US20080243087, last dose lockout mechanism in US20100324494 comprising rotatable shaft and non-rotating member, nut member in US 20090137964, rotating in US20080108953 and US20090240195 bushing.

Contents of the invention

An aspect of the invention may be that the fluid delivery pen may have a dose setting mechanism by which when a dose setting or a set dose changes, i.e. increases or decreases, is identifiable by a change in the degree of the click, That is, it is preferred to have a higher audibility when the dose is set and a lower audibility when the dose is reduced.

Another aspect of the present invention may be that the fluid delivery pen has a final dose stop mechanism to allow delivery not only by ensuring that all of the fluid in the cartridge can be delivered (i.e. the remaining amount of fluid in the cartridge is as small as practically allowable) but also by the dose setting. The indication of the setting mechanism avoids wasting fluid, and when the last dose or final dose setting is delivered, the amount of fluid that has not been delivered can be inferred. This allows the user to set and inject the dose from a new disposable fluid delivery pen device. By the last dose stop mechanism it may be indicated that no fluid remains in the cartridge after the final dose is delivered.

Yet another aspect of the invention may be that the fluid delivery pen may have a dose drive mechanism that may have reduced friction through improved shape and suitable length of the finger pad and reduced mating contact surface with the dose setting member Minimizing the force the user has to exert to inject the dose ensures easier and precise dose delivery.

Yet another aspect of the present invention may be that the fluid delivery pen may be more slender, reduced diameter of various key components (eg, housing, dose setting barrel, and dose knob), and reduced overall weight and length.

Yet another aspect of the invention may be that the fluid delivery pen cap or cap has an internal orientation, which not only gives a more aesthetic appearance, but also snaps more securely or securely onto the filler cap or fluid filler holder for better to protect internal components.

Yet another aspect of the invention may be that the fluid delivery pen has an audible click when the dose dial returns to the "0" index.

The exterior of the fluid delivery pen of the present invention may include a cap and an outer body. The cap can enclose a drug vial or a cartridge. The outer body may house dose setting/indexing and dose drive mechanisms. Shock resistance of these components is critical to protecting the mechanism and fluid contents.

The desired dose index selection can be entered by the user by turning the dose scale coil knob. The tactile feedback may be given by dialing up or down the ratchet teeth formed in the ratchet cap and clutch tube, respectively. Each ratchet can act against an array of teeth, wherein each tooth in the array of teeth can represent a single dosage unit. During indexing or dose setting, the dose dial coil tube is free to rotate relative to the fixed clutch tube with the aid of a spring loaded dog clutch mechanism. The maximum dose setting may be determined by a channel extending longitudinally in the clutch tube.

To deliver the selected dose, the user may apply force on the finger pad. This force is transferred to the clutch tube through the ratchet cap, locking the clutch tube to the dose dial coil. Thus, as the dose dial coil rotates, the clutch tube may also rotate until the dose dial coil may abut against the outer body zero scale stop.

During dose delivery, the rotational action of the clutch tube may be related to the drive shaft spline via diametrically opposed lugs. The drive shaft keyway can then rotate over a one-way ratchet on the inner body. Rotation can be transferred to the drive shaft via a square/rectangular hole on the drive shaft keyway which can fit over a similar square/rectangular head of the drive shaft. Two diametrically opposed lugs on the hollow piston rod run along channels in the inner body, preventing rotation of the hollow piston rod during dosing. A hollow piston rod lug may engage the end of the inner body channel, locking the pen mechanism against further delivery. This can act as an indicator to the user that the final dose has been delivered.

A cartridge or bottle can be fitted within the cartridge cap. It may be axially aligned by a series of ribs which may extend longitudinally inside the cartridge cap. The head and neck of the cartridge can be located within the head and neck region of the cartridge cap. The filler cap can be secured within the pen assembly by an outer circular rib that can mate with a circular channel on the inside of the outer body. A series of ribs distributed around the inside surface of the outer body may facilitate axial alignment. The two snap protrusions are also positioned diametrically opposite for linear clamping and rotational orientation of the fitted cap.

Technical terms used in the present invention may be as follows. The part in the assembled pen or the distal end of the assembled pen is the end corresponding to the dose setting end. The part of the assembled pen or the distal end of the assembled pen is the end corresponding to the delivery end.

Fluids as used in the present invention may be interpreted as pharmaceutically active components, including insulin, insulin analogs, and the like.

A fluid delivery pen according to the present invention may comprise a cartridge cap for a fluid containing cartridge, two concentrically arranged housing bodies - an outer body and an inner body, and two concentrically arranged dose cartridges - a dose dial coil and clutch tube. The filler cap can hold the fluid containing the filler. The cartridge can carry a needle at its distal end. The cartridge can carry a plunger at its proximal end. The proximal end of the filler cap can have retaining ribs adapted to engage the outer body retaining channel to retain the filler cap into the outer body. An orientation notch disposed distally relative to the proximally positioned retention rib can be aligned with the inner body orientation tooth and pen assembly. The upper fit/attachment of the parts inner body, outer body, and cartridge cover ensures secure and proper alignment.

The proximal half of the fluid delivery pen comprises a housing comprising inner and outer bodies enclosing the dose setting/dose indexing and drive mechanisms. Two concentrically arranged clutch tubes and dose dial coils may be placed between the inner and outer bodies. The outer body and inner body may be held in place by the cooperation of the inner rib wall distal to the last dose click rib on the inner surface of the outer body with the datum surface and detent of the inner body. The inner rib wall located distal to the last dose click rib on the inner surface of the outer body serves two functions. First, the inner rib walls of the outer body contact the datum surface of the inner body to secure the linear fit of the pen assembly. Second, the inner rib walls, opposite the inner body detents of the inner body, are fitted through the holes and eventually cooperate to retain the inner body. Furthermore, the outer body and the inner body may be connected to a diametrically opposed anti-rotation notch on the proximal end of the inner body distal to the datum plane by means of diametrically opposed anti-rotation ribs disposed along the inner rib wall side on the inner surface of the outer body. The fits are prevented from rotating relative to each other.

Alignment ribs on the inner surface of the outer body toward the distal end of the outer body and distal to the inner rib wall can provide a concentric location of the cartridge cap and can aid in fastening and secure positioning to the outer body. A last dose click rib may be located on the inner surface of the outer body proximal to the proximal end of the inner rib wall, the last dose click rib being positioned in contact with a zero stop recess on the distal surface of the dose dial coil Mouth-to-corner final dose click ratchets together to create a click. A zero-stop rib on the inner surface of the outer body may begin in the proximal direction at the proximal end of the inner rib wall and terminate at the nearest circumferential helical rib. A zero stop notch on the distal surface of the dose dial coil may act as a rotational stop for the dose dial coil, establishing a threaded relationship by its engagement with the zero stop rib as the pen returns to zero scale during delivery of fluid. The outer body may have helical ribs circumferentially disposed on its inner surface, which may interact with helical channels circumferentially disposed on the outer surface of the dose dial coil while setting the dose or decreasing the dose. Cooperate. The outer body may have a circular snap-in channel internally disposed at its distal end, which may act as a concave-convex feature, which is retained by a retainer provided on the proximally-facing outer surface of the outer surface of the filler cap. The ribs snap together to hold the cartridge cap. This holds the cartridge cap in the outer body.

A fluid delivery pen may include a dose setting/indexing mechanism and a drive mechanism. The fluid delivery pen drive mechanism of the present invention is characterized by reduced friction during dose delivery, which allows for ease of dose delivery by the user. The fluid delivery pen drive mechanism of the present invention has the added feature of indicating end-of-dose of fluid in the cartridge. The fluid delivery pen does not use rotatable parts or a separate movable but non-rotating member, unlike known fluid delivery pens that have an externally threaded piston rod with threaded features for the end-of-dose mechanism. When the component may be an axially moving component with threaded features, it may be susceptible to wear. As a result of wear, inaccuracies may be set in the indication not only of repeated set doses but also of remaining doses that may need to be delivered. Rotatable components with threaded features may be disadvantageous due to the high cost precision manufacturing of the components which can increase equipment cost. Also, it is desirable that the piston rod can have a robust design. The externally threaded piston rods of the prior art have a relatively small diameter and thus may be easily damaged or deformed. Small fragility or deformation of the externally threaded piston rod may further increase the chances of failure of the end-of-dose mechanism through threaded engagement of the rotatable member with the externally threaded piston rod, which may not be a desired feature. Also, a piston rod with a non-locking internal helical thread may be substantially larger in diameter and have a structurally efficient hollow section, making it substantially stronger than an equivalent externally threaded rod.

The drive mechanism may comprise a hollow piston rod with internal threads and a drive shaft with external helical ribs. The drive shaft spline may be considered part of the drive mechanism as the drive bore of the drive shaft spline may transfer the rotation of the drive shaft spline to the drive shaft during dose delivery. The proximal portion of the drive shaft includes the drive head, collet and shoulder bearing. Furthermore, the drive shaft spline forming part of the drive mechanism includes an array of teeth on its proximal portion. The distal portion of the drive shaft keyway includes a clip finger, a drive lug, and a rotational bearing.

The drive shaft may be cylindrical and may have helical ribs disposed on its outer surface. The hollow piston rod may be cylindrical and may have helical threads provided on its inner surface. The helical ribs may cooperate with the helical threads, which may translate rotational activation of the drive shaft into linear displacement of the hollow piston rod during dose delivery. The pitch on the drive shaft determines the ratio of rotational motion to linear displacement. A shoulder bearing, which may be cylindrical, may be located at the proximal end of the drive shaft. This shoulder bearing can divert linear back pressure due to actuation of the cartridge against the inner body bearing surface. The proximal end of the drive head towards the drive shaft is located between the shoulder support and the chuck. The drive head surface is mateable with the complementary drive bore surface of the drive shaft keyway. The engagement of the drive head surface with the complementary drive bore surface of the drive shaft spline may divert rotation from the drive shaft spline during dose delivery. The collet may be located proximally of the drive head and proximally of the drive shaft. The clip mates with the drive shaft keyway clip to retain the drive shaft keyway within the pen assembly. Two diametrically opposed anti-rotation lugs may be located at the proximal end on the outer surface of the hollow piston rod, said anti-rotation lugs interacting with the inner body anti-rotation channel. The anti-rotation lugs can be two rectangular protrusions whose side surfaces can interact with the inner body anti-rotation grooves. The interaction between the anti-rotation lug and the inner body anti-rotation channel can limit rotation of the hollow piston rod during dose activation while converting drive shaft rotation into linear hollow piston rod motion. The distal vertical surfaces of the diametrically opposed anti-rotation lugs of the proximal end of the hollow piston rod may form a blocking surface upon stopping contact with a last dose distal to the reference plane towards the distal end of the inner body. Contact between the blocking surface and the last dose stop prevents linear displacement of the hollow piston rod, indicating the end of fluid in the cartridge. This may also be referred to as a last dose stop, since no fluid can be delivered from the fluid delivery pen. A circular piston flange may be located at the distal end of the cylindrical hollow piston rod, which circular piston flange may push the cartridge plunger during dose delivery.

A fluid delivery pen dose setting/indexing mechanism may include a dose dial coil, clutch tube, ratchet cap and finger pad. The dose dial coil and clutch tube are located concentrically between the inner and outer bodies. The ratchet cap may be positioned between the clutch tube and the dose dial coil towards the proximal ends of the clutch tube and the dose dial coil. The finger pads are located at the proximal end of the ratchet cap. The fluid delivery pen dose setting/indexing mechanism of the present invention is characterized by reduced friction during dose delivery, which may allow for ease of dose setting and dose delivery by the user. Another additional feature of the fluid delivery pen dose setting mechanism is that it can produce a high audible sound for each click corresponding to a unit dose setting and for each click when the set dose is reduced Produces a sound of lower audibility than the former. A dose setting mechanism in a fluid delivery pen that produces sound when setting or decreasing a dose may seek to reduce friction between the finger pad and ratchet member, reducing overall friction of the pen assembly during actuation/use. Reduced friction can be achieved by reducing the diameter of the force contact area via the shaft/spindle, whereby the user can apply direct loads to the mechanism. Stability between parts can be equally important in reducing friction. As such, components can be held using specific support surfaces. This could be, for example, a continuous surface or a series of ribs at each end of the rotating mandrel. These support features prevent rocking between parts and also provide minimal contact surfaces for rotational friction.

The clutch tube has two diametrically opposed one-way ratchets at its proximal end which act against the one-way ratchet teeth of the ratchet cap to provide a click during downward indexing of the dose. The clutch tube has two diametrically opposed clutch springs at its distal end which act against the distal circumferentially inner ribs of the dose dial coil to disengage them during dial setting/dose setting. Dog teeth on the far side of the dial knob undercut. Four longitudinal channels extend circumferentially over the inner surface of the clutch tube in part from distal to proximal ends, their distal ends performing the function of four hard stops that are maximum scale stops. The positioning of the four longitudinal channels of the clutch tube and the four drive lugs on the keyway of the drive shaft allows the drive lugs to move in a linear motion along the clutch tube channels. The four longitudinal channels perform two of the functions of the fluid delivery pen. First, it provides telescoping linear motion to the drive shaft keyway during indexing of up/down doses. Second, it can transfer the rotary actuation to the drive shaft spline during dosing of fluid. Four dog teeth may be disposed at 90° to each other on the outer surface of the clutch tube distal to the drive shoulder. During fluid dosing, the dog teeth of the clutch tube may engage the dosing dial coil dog teeth to engage the dosing mechanism. The circular drive shoulder may be located distally of the teeth of the one-way ratchet and proximally of the dog teeth of the clutch. The drive shoulder can carry input force from the ratchet cap drive shoulder to engage the clutch mechanism during dose activation.

A functional description of the dose dial coil can be described as follows. The dose dial coil may be cylindrical, referred to as the proximal portion of the dose dial knob having a larger diameter than the distal portion. A zero stop notch may be provided on the outer surface of the distal end of the dose dial coil. This may act as a rotation stop against an outer body zero stop on the inner surface of the outer body that extends longitudinally along the proximal anti-rotation and starts at the distal end of the inner rib wall and ends at the nearest circumference Spiral ribs. The dose dial handle may be a circumferential rib that may be provided on the outer surface of the dose dial knob of the dose dial coil tube, the circumferential rib may lead from the proximal end to the distal end of the dose dial knob. The dose dial handle facilitates easier control of the dose dial knob during dose indexing. The dose dial knob may be a proximal portion of the dose dial coil, and the proximal portion of the dose dial coil may have a larger diameter than the smaller diameter distal portion. A helical channel may be provided on the outer surface of the dose dial coil and may interact with the helical rib of the outer body to form a cooperating threaded relationship. A last dose click ratchet positioned diagonally opposite the zero stop notch engages a dose click rib on the inner surface of the outer body when the pen returns to the zero scale. Dose scales may be disposed circumferentially on the outer surface of the dose scale coil and may indicate the number of dialed units of fluid to be delivered. Dosage scales may range from 0 to 60 units or greater in steps of 1 unit. The circular dose dial knob undercut may be located distally of the ratchet teeth and proximally of the dog teeth. The dose dial knob undercut performs two functions. First, it keeps the ratchet cap inside the dose dial coil head. Second, it provides linear clearance for dog clutches. Clutch action may include decoupling during indexing/dose setting or engagement during dose delivery. A dog located distal to the undercut of the dose dial knob may engage the clutch tube dog upon depression of the finger pad, resulting in engagement of the dosing mechanism. A circular inner rib may be provided on the inner surface proximal to the distal end of the dose dial coil, which may act against the clutch spring to disengage the dog teeth during indexing/dose setting. Ratchet teeth may be provided on the inner surface of the dose dial knob of the dose dial coil tube, may extend from the proximal side to the distal end thereof and terminate at the proximal end of the dose dial knob undercut. The ratchet teeth can ratchet against the ratchet cap one-way ratchet which can act against the dose dial coil ratchet teeth to provide a click during indexing up/dose setting. Up indexing/dose setting may indicate that the dose is set in an incremental manner. Each tooth of the ratchet teeth may correspond to a single dose increase displayed on the dose dial coil scale.

The finger pad may be part of the dose setting/injection assembly and may be present at the proximal end of the injection device. The finger pad may be cylindrical and includes a cylindrical pin, a single tooth, a running surface and a dose button. The peripheral surface of the shaft pin may form a rotational bearing.

A ratchet cap can be considered to have a distal portion and a proximal portion. The proximal and distal portions of the ratchet cap may be integrally molded or may be joined by other attachment means. The ratchet cap serves as a component during operation of the fluid delivery pen. A distal end of the distal portion of the ratchet cap may have a larger diameter than a proximal end of the distal portion of the ratchet cap. The proximal portion of the ratchet cap may include retaining ribs, a running surface rotational bearing, and an axle bore. Three retaining ribs may be disposed at the proximal end of the proximal portion of the ratchet cap at 120° relative to each other. A distal inner surface of the proximal portion of the ratchet cap, which may extend partially to the distal portion of the ratchet cap, may form a running surface. The inner circular proximal and distal surfaces of the proximal portion of the ratchet cap can serve as rotational bearings. A circular opening extending from the proximal end of the proximal portion of the ratchet cap to the running surface of the proximal portion of the ratchet cap forms the shaft bore. The distal portion of the ratchet cap may include one-way ratchet teeth, one-way ratchet teeth, a shaft bore, a drive surface, and an outer rib. The distal portion of the ratchet cap can be cylindrical/circular and its distal end can have a circular outer rib whose distal face can form a drive surface. The proximal side of the outer rib may be two diametrically opposed one-way ratchets. The one-way ratchet may be formed by a central diameter cut portion on the outer surface of the ratchet cap. Proximal to the outer rib in the distal portion of the ratchet cap, one-way ratchet teeth are disposed circumferentially on its inner surface.

The working mechanism between the finger pad and the ratchet cap during fluid delivery pen operation may be as follows. The finger pad cross assembly can be retained with the ratchet cap by snapping the finger pad clip teeth onto the ratchet cap retaining rib. Also, the finger pad pivot pin can be aligned with the ratchet cap pivot hole. The mating of the finger pad rotational bearing with the ratchet cap shaft hole can provide lateral stability between the finger pad pivot pins and reduced friction between the finger pad and ratchet cap. The running surface of the finger pad can mate with the running surface of the ratchet cap. The user can apply force on the dose button, which force can be transferred from the running surface of the finger pad to the running surface of the ratchet cap through the finger pad pivot pin. User input force may also be transferred through the drive surface to cause engagement with a dog ratchet mechanism comprising a clutch tube dog and a dose dial tube dog to activate delivery of a dose. The mating of the rotational bearing surface of the ratchet cap and the rotational bearing surface of the finger pad provides lateral stability between the finger pad pivot pin and the ratchet cap pivot hole.

The working mechanism between the ratchet cap, clutch tube and dose dial coil of the fluid delivery pen may be as follows. During upward dose indexing/dose setting, the dose dial coil is rotatable in a clockwise or counterclockwise direction depending on the helical orientation of the helical channel on the dose dial coil and the helical rib on the inner surface of the outer body. If the orientation of the helical channel on the dose dial coil may be right handed, the dose dial coil may rotate in a clockwise direction during upward dose indexing/dose setting. If the orientation of the helical channel on the dose dial coil may be left handed, the dose dial coil may rotate in a counterclockwise direction during upward dose indexing/dose setting. During upward dose indexing/dose setting, the one-way ratchet of the ratchet cap can act against the dose dial coil ratchet teeth, causing a click. During indexing down/dose setting, the clutch tube one-way ratchet can act against the one-way ratchet teeth of the ratchet cap to provide a click. Since the size of the one-way ratchet of the ratchet cap can be larger than the size of the one-way ratchet of the clutch tube, the upward dose indexing/dose setting is more effective against the dose dial coil ratchet teeth than against the one-way ratchet of the ratchet cap. Down indexing/dose setting click when ratchet teeth are engaged Highly audible click. The ratchet cap drive face carries the input force transferred from the finger pads through the ratchet cap running face to the clutch tube drive shoulder. This input force can cause the clutch tube dog to engage the dose dial coil dog, resulting in engagement of the dosing mechanism during fluid delivery. Once fluid can be fully administered, during the next up or down indexing/dose setting for subsequent fluid delivery, the dose dial coil inner ribs can act against the clutch tube spring to disengage the dog teeth, facilitating all The desired dose setting is completed. The engagement of the clutch tube dog to the dose dial dog by finger pad force transfer and the disengagement of the clutch tube dog from the dose dial dog during the next up or down index/dose setting can be fluid The key to the functionality of the delivery pen.

Some embodiments of the invention are described below. The various embodiments may serve only to illustrate the present invention. It should be understood, however, that they do not limit the scope of the invention in any way. However, those skilled in the art will be able to make various modifications to the individual parts of the delivery device, for example, changes to the cartridge holder or dosing cartridge, plunger, etc., to arrive at a similar functional design, and the invention is considered to include all these modifications.

Specific embodiments of the present invention are described in detail with reference to the accompanying drawings. The delivery devices described in the embodiments below have the general shape and appearance of a pen, and are described in these embodiments as fluid delivery pens.

Description of drawings

Figure 1 is a front 3/4 view of a fully assembled fluid delivery pen with the cap in place;

Figure 2 is a cross-sectional view of a fluid delivery pen through a dose window;

Figure 3 is a cross-sectional view of the fluid delivery pen at 90° relative to Figure 2;

Figure 4 shows the hollow piston rod of the fluid delivery pen in an initial position;

Figure 5 shows the hollow piston rod of the fluid delivery pen in an intermediate position;

Figure 6 shows the hollow piston rod of the fluid delivery pen in the end-of-dose position;

Figure 7 shows a fluid delivery pen with a cross-sectional view of the final dose stop in the initial use position;

Figure 8 shows a fluid delivery pen with a cross-sectional view of the final dose stop in the end-of-dose position;

Figure 9 shows a fluid delivery pen with a rear 3/4 view of the hollow piston rod in the initial use position;

Figure 10 shows a fluid delivery pen with a front 3/4 view of the hollow piston rod in the initial use position;

Figure 11 shows a fluid delivery pen with a rear 3/4 view of the hollow piston rod in the halfway position;

Figure 12 shows a fluid delivery pen with a front 3/4 view of the hollow piston rod in an intermediate position;

Figure 13 shows a fluid delivery pen with a rear 3/4 view of the hollow piston rod in the end-of-dose position;

Figure 14 shows a fluid delivery pen with a front 3/4 view of the hollow piston rod in the end-of-dose position;

Figure 15 shows components of a fluid delivery pen's click mechanism;

Figure 16 shows a fluid delivery pen - X-section arrow;

Figure 17 shows section C-C of Figure 16 - dose dial coil and ratchet cap unidirectional ratchet feature;

Figure 18 shows section D-D of Figure 16 - ratchet cap and clutch tube one-way ratchet feature;

Figure 19 shows section E-E of Figure 16 - inner body and drive shaft keyway one way ratchet feature;

Fig. 20 shows the section F-F of Fig. 16 - piston rod square rotation characteristic;

Figure 21 shows section G-G of Figure 16 - the last dose click and zero stop feature;

Figure 22 shows section H-H of Figure 16 - inner body square turn and alignment rib features;

Figure 23 shows an exploded rear 3/4 view of the fluid delivery pen components;

Figure 24 shows an exploded front 3/4 view of the fluid delivery pen components;

Figure 25 shows a ratchet cap for a fluid delivery pen, features with linear bearing surfaces;

Fig. 26 shows a ratchet cap component of a fluid delivery pen with an aperture feature and a rotating bearing surface;

Figure 27 shows a finger assembly of a fluid delivery pen with protruding features, linear and rotational support; and

Figure 28 shows a cross-sectional view of the assembled components showing all key features and surfaces of the fluid delivery pen.

detailed description

Figure 1 shows the fluid delivery pen in fully assembled and capped form. This figure illustrates an embodiment of the invention wherein the delivery device has the general shape and appearance of a pen. Figure 1 therefore illustrates the cap cartridge (PC3), cap clip (PC2), dose dial window (OB6), dose dial handle (DDT2), dose scale (DDT6) and dose dial knob (DDT3 ). Figure 24 shows an exploded view of all fluid delivery pen components.

Referring to the embodiment shown in Figures 2, 3, the fluid delivery pen can be described as comprising two regions. The distal half of the pen includes the cartridge cap (1 ) for retaining fluid (6) to accommodate the cartridge (2). A needle holder (3) can be installed on the far end of the perfusion device cover (1), and the needle holder (3) carries the needle (4). The part of the needle (4) protruding from the cartridge cover (1) may be enclosed by a protective needle cover (5). The proximal end of the needle can communicate with the fluid (6) of the cartridge. The cartridge (2) containing the fluid (6) can be located within the cartridge cap (1) such that the head (7) and neck (8) of the cartridge can be tightly secured to the neck region (9) of the cartridge cap (1). ). The distal end of the cartridge can be sealed, but the proximal portion of the needle can pass through it in fluid communication with the cartridge (6). The proximal end of the cartridge can be closed by an airtight but movable plunger (10, 10d) (10d) after all available medicament has been completely expelled, wherein the plunger (10, 10d) (10d) is . The outer surface of the proximal end of the filler cap (1) may have a helical thread (11).

The proximal half of the fluid delivery pen comprises a housing comprising an inner body (IB) and an outer body (OB) enclosing the dose setting/dose indexing and drive mechanisms. The outer body (OB) and the inner body (IB) can meet the datum surface ( IB9) and the bayonet (IB6) proximal to the datum (IB9) are held in place by the fit (see Figures 2, 3, 9, 11 and 13). The inner body (IB) may have diametrically opposed unidirectional ratchets (IB4) disposed on the proximal end. The bearing surface (IB1) may be located distal to the one-way ratchet (IB4) on the proximal end of the inner body (IB). The bearing surface (IB1) may be a circular surface provided on the inner surface of the inner body (IB). Diametrically opposed anti-rotation channels (IB7) leading from the proximal end to the distal end of the inner body (IB) may be located distally of the bearing surface. It may be noted that the diametrically relative positions of the anti-rotation notch (IB2), last dose stop (IB5) and anti-rotation channel (IB7) of the inner body (IB) may refer to the last dose stop (IB5) position. In one embodiment of the invention the anti-rotation notch (IB2), last dose stop (IB5) and anti-rotation groove (IB7) and orientation tooth (IB3) may all be on the same line. The continuation of the anti-rotation channel (IB7) towards its distal end may form a bayonet channel (IB8). The inner rib walls (OB7) and anti-rotation ribs (OB8) of the outer body (OB) are positioned proximally of the circular card channel (OB5) towards its distal end. The inner rib wall (OB7) located distal to the last dose clicker rib (OB2) on the inner surface of the outer body (OB) has two functions. First, the inner rib wall (OB7) of the outer body (OB) contacts the datum surface (IB9) of the inner body (IB) to secure the linear fit of the pen assembly. Secondly, the inner rib wall (OB7) is opposite to the inner body latch (IB6) on the outer surface of the inner body (IB) near the reference plane (IB9), and the inner rib wall (OB7) and the latch (IB6) pass through The holes fit and eventually mate to hold the inner body (IB). Also, the outer body (OB) and the inner body (IB) can communicate with the inner body (IB) through the anti-rotation rib (OB8) provided along the inner rib wall (OB7) side on the inner surface of the outer body (OB). The fit of the diametrically opposed anti-rotation notches (IB2) on the proximal end distal to the reference surface (IB9) of the distal end (as shown in Figs. 22, 16, section H-H) is prevented from rotating relative to each other. The position of the anti-rotation rib (OB8) will be in line with the last dose stop (IB5) provided on the outer surface of the distal end of the inner body (IB).

The drive shaft (31) may be cylindrical and may have helical ribs (36) provided on its outer surface. The proximal portion of the drive shaft (31) includes a drive head (DS2), a chuck head (DS3) and a shoulder support (31'). Referring to Figures 7 and 8, a drive shaft key (DSK) may be located on the proximal portion of the drive shaft (31). The proximal portion of the drive shaft key (DSK) may be cylindrical with varying diameters, with the proximal end having a larger diameter than the distal end. Four drive lugs (DSK4) may be located on the outer peripheral surface of the proximal cylindrical portion of the drive shaft keyway (DSK), as shown in FIGS. 9 , 11 , 12 , 13 and 14 . A rectangular drive hole (DSK3) can be centrally routed from the proximal end to the distal end, as shown in Figures 7 and 8. Two clipping fingers (DSK2) may protrude from the proximal outer peripheral surface of the drive shaft keyway (DSK), as shown in FIGS. 11 and 8 . The proximal small diameter portion of the drive shaft keyway (DSK) can form a swivel bearing (DSK5), as shown in Figures 7 and 8. Furthermore, the drive shaft keyway (DSK) forming part of the drive mechanism comprises an array of teeth (DSK1 ) on the circumferential surface of its distal portion. The proximal portion of the drive shaft keyway (DSK) includes clip fingers (DSK2), drive lugs (DSK4) and swivel bearings (DSK5). A circumferential array of teeth (DSK1) may be provided on the distal portion of the cylindrical surface of the drive shaft keyway (DSK1) as shown in FIGS. 4, 5, 6, 10, 12 and 14. The hollow piston rod (30) may be cylindrical and may have a helical thread (37) provided on its inner surface. The helical rib (36) may cooperate with the helical thread (37) and this may translate rotational activation of the drive shaft (31) into linear displacement of the hollow piston rod (30) during dose delivery. The pitch on the drive shaft (31) determines the ratio of rotational motion to linear displacement. A shoulder support (31') may be located at the distal end of the proximal portion of the drive shaft (31), the shoulder support (31') may be cylindrical. The cooperation of the proximal shoulder bearing (31') with the inner body bearing surface (IB1) can divert the linear back pressure caused by the actuation of the cartridge (2). The drive head (DS2) may be located between the proximal shoulder support (31') and the proximal chuck head (DS3). The drive head (DS2) can be rectangular or square or any other geometric shape. The drive head (DS2) face mates with the complementary drive bore (DSK3) face of the drive shaft keyway (DSK). This engagement of the drive head (DS2) surface can divert rotation during dose delivery from the drive shaft keyway drive hole (DSK3), where the drive hole (DSK3) extends from the proximal end to the distal end. The chuck (DS3) may be located proximally of the drive head (DS2) and proximally of the drive shaft (31). Two clips (DS3) mate with complementary drive shaft keyway clips (DSK2), which facilitate retention of the drive shaft keyway (DSK) within the pen assembly. Two diametrically opposed anti-rotation lugs (PR1) may be located on the proximal end of the outer surface of the hollow piston rod (30), wherein the anti-rotation lugs (PR1) interact with the inner body (IB7) anti-rotation channel (IB7) effect. It may be noted that the diametrically relative positions of the anti-rotation lug (PR1 ) and blocking surface (PR3) of the piston rod (30) may be referred to with reference to the position of the last dose stop (IB5) of the inner body (IB). In one embodiment of the invention, the anti-rotation lug (PR1 ) and blocking surface (PR3) of the piston rod (30) will be on the same line as the last dose stop (IB5) of the inner body (IB). The anti-rotation lugs (PR1) can be two rectangular protrusions whose side surfaces can interact with the inner body (IB) anti-rotation channels (IB7). The interaction between the anti-rotation lug (PR1) and the inner body (IB) anti-rotation channel (IB7) allows for simultaneous translation of drive shaft (31) rotation into linear hollow piston rod (30) movement during dose activation. The rotation of the hollow piston rod (30) is restricted (see Figures 13 and 14). The distal vertical surface of the proximal diametrically opposed anti-rotation lug (PR1) of the hollow piston rod (30) can form a diametrically opposed blockade surface (PR3) that can be in contact with the distal end of the inner body (IB). The last dose stop (IB5) contacts proximal to the reference plane (IB9) of the 100 (see Figures 13 and 14). Contact between the blocking surface (PR3) and the last dose stop (IB5) prevents the linear displacement of the hollow piston rod (30), indicating the end of the fluid (6) of the cartridge (2). Figures 4, 5 and 6 show in dashed lines the hollow piston rod (30) of the fluid delivery pen in the dose initiation, mid-dose and end-of-dose positions. The position of the plunger (10) is shown in dashed lines in initial, intermediate and end positions. Figure 7 shows a cross-sectional view of the fluid delivery pen with the last dose stop (matching of the last dose stop (IB5) with the blocking surface (PR3)) in the initial use position. Figure 8 shows a cross-sectional view of the fluid delivery pen with the final dose stop (ie the cooperation of the last dose stop (IB5) with the blocking surface (PR3)) in the end of dose position. In FIG. 8 there is shown a gripper finger (DSK2) which can cooperate with the drive head (DS2). No fluid (6) can be delivered from the fluid delivery pen after the engagement of the last dose stop (IB5) with the blockade surface (PR3). A circular piston flange (PR2) may be located at the distal end of the cylindrical hollow piston rod (30), which piston flange (PR2) may push the cartridge plunger (10) during dose delivery.

Figures 9 and 10 show rear 3/4 and front 3/4 views, respectively, of the fluid delivery pen hollow piston rod (30) in the initial use position shown in phantom. As can be seen in Figure 10, the anti-rotation notches (IB2), latches (IB6) and reference surfaces (IB9) of the inner body (IB) are not visible. Figures 11 and 12 show rear 3/4 and front 3/4 views, respectively, of the fluid delivery pen hollow piston rod (30) in the half-way position shown in phantom. Figures 13 and 14 show rear 3/4 and front 3/4 views respectively of the fluid delivery pen hollow piston rod (30) in the end-of-dose position shown in phantom.

Referring to Figures 2 and 3, the alignment rib (OB1) distal to the inner ribbed wall (OB7) on the inner surface at the distal end of the outer body (OB) provides a concentric position for the cartridge cap (1) and facilitates tight fit. Secure and securely positioned to the outer body (OB). The last dose click rib (OB2) may be located on the inner surface of the outer body (OB) proximal to the proximal end of the inner rib wall (OB7), the last dose click rib (OB2) at the distal end of the dose dial coil (DDT). The zero stop notch (DDT1 ) on the side surface creates a click when mated diagonally opposite the last dose click ratchet (DDT5). The zero stop rib (OB3) on the inner surface of the outer body (OB) may start longitudinally in the proximal direction from the proximal end of the inner rib wall (OB7) and terminate at the nearest circumferential helical rib (OB4). The zero stop rib (OB3) may have a rectangular shape. The zero stop notch (DDT1) on the distal surface of the dose dial coil (DDT) can act as a dose scale by its cooperation with the zero stop rib (OB3) (shown in Figure 21, section G-G of Figure 16) The rotation of the coil is stopped at the zero dose scale. The outer body (OB) may have helical ribs (OB4) circumferentially disposed on its inner surface, which may be combined with helical grooves circumferentially disposed on the outer surface of the dose dial coil (DDT) DDT4), where the dose dial coil (DDT) can establish a thread relationship while setting the dose or reducing the dose. The outer body (OB) can have a circular card slot (OB5) arranged inside its distal end, and the circular card channel (OB5) can serve as a concave-convex feature, which can be connected with the outer surface of the filler cover (1). The retaining ribs (CC4) on the proximally facing outer surface snap to retain the cartridge cap (1). This keeps the cartridge cover (1) in the outer body (OB). A dose dial window may be provided on the proximally facing outer surface of the outer body (OB) to allow viewing of the set dose.

The pen cap (PC) can encapsulate the medicine bottle or the perfusion device (2) and the needle assembly. The perfusion device (2) includes the perfusion device neck (8), the perfusion device head (7), and the perfusion device packaged in the perfusion device cap (1). In the neck region (9), the needle assembly includes a hub (3), a needle (4) and a needle cap (5). The pen cap (PC) can be removed to allow fitting of the needle and injection of the dose, and refitted to protect it from contamination.

Referring to Figure 23, the features of the cartridge cap (1) that allow it to be attached to the pen assembly can be explained as follows. Diametrically opposed rotational orientation (CC2) features, circular retention ribs (CC4) and orientation notches (CC6) are provided on the outer surface of the cartridge cap (1) towards the proximal portion of the cartridge cap (1). An orientation notch (CC6) may be located on the proximal outer surface of the cartridge cover (1 ) and may be aligned with the viewing window (CC3). The orientation notch (CC6) is positioned on the cartridge cap (1) so that it aligns with the orientation tooth (IB3) of the inner body (IB). The orientation notch (CC6) may be rectangular in shape, formed by a cutout in the distal peripheral surface of the cartridge cap (1). A circular retaining rib (CC4) may be located on the outer surface of the cartridge cap (1 ), distal to the distal end of the orientation notch (CC6) and proximal to the rotational orientation feature (CC2). The diametrically opposed rotational orientation (CC2) feature may be located on the outer surface distal to the circular retaining rib (CC4) and proximal to the viewing window (CC3). One of the rotation retaining features (CC2) can be aligned with the orientation notch (CC6) and viewing window (CC3). The rotational orientation feature (CC2) may be a protrusion on the outer surface of the cartridge cap (1 ) comprising a central horizontal rectangular surface and two inclined rectangular surfaces attached at an angle to the horizontal rectangular surface.

Figures 1, 2, 3 and 23 illustrate various features of the pen cap (PC) and its cooperation with the cartridge cap (1 ) to provide a secure grip. The distal portion of the pen cap (PC) includes three alignment ribs (PC4) on its inner surface and a triangular cap core (PC3) on its distal end. Three alignment ribs (PC4) are provided on the inner surface of the pen cap (PC), extending partially from the distal end to the proximal end at 120°, which can facilitate the pen cap (PC) on the filler cap (1) or Axial alignment of the attached hub (3) and cover. The position of one of the alignment ribs (PC4) may be in line with the last dose stop (IB5) on the outer surface of the distal end of the inner body (IB). For reference, the other two alignment ribs (PC4) are at 120° to it. The proximal portion of the pen cap (PC) includes an orientation feature (PC1 ) and a circular card channel (PC5) on its inner surface. The location of the orientation feature (PC1) on the inner surface of the pen cap (PC) is in-line with the last dose stop (IB5) on the distal outer surface of the inner body (IB). Cap (PC) can occur when an orientation feature (PC1) on the inner surface of the proximal end can be aligned with the rotational orientation (CC2) of the cartridge (1) by placing the cap (PC) on the cartridge cap (1). PC) to secure clamping of the perfusion cap (1). The cap clip (PC2) is accessible from the distal end to the proximal end, which facilitates securely storing the fluid delivery pen in the pocket. Providing a cap core (PC3) on the distal end of the cap (PC3) can enhance the aesthetics of the pen. A circular snap channel (PC5) that can be circularly aligned with an orientation feature (PC1 ) at the proximal end of the pen cap (PC) can act as a relief feature that snaps to the cartridge cap (1 ) for a secure grip. Orientation teeth (IB3) can be provided at the distal end of the inner body (IB), and the orientation teeth (IB3) can cooperate with the proximal orientation notches (CC6) of the filler cap (1). This fit ensures alignment of the cartridge cap (1) with the pen assembly. The distal end of the cartridge cap (1 ) can have threads, which can be attached to the needle assembly. The cartridge cover (1 ) may have two diametrically opposed viewing windows (CC3) on its outer surface that allow direct visibility of the cartridge to the remaining fluid (6).

The features of the cartridge ( 2 ) and its cooperation with the cartridge cover ( 1 ) can be explained below with reference to FIGS. 2 , 3 and 23 . The cartridge (2) may be a standard cartridge comprising a cartridge body which may contain 3ml or 1.5ml or any other volume varying between 0.3ml and 3ml. The cartridge body can be in contact with four alignment ribs (CC5) (not shown in Figure 23) of the cartridge cover (1) provided on the inner surface of the cartridge cover (1). Four alignment ribs (CC5) provide concentric axial location for the glass cartridge (2). A metal buckle can hold the septum and can apply pressure to the septum to seal the cartridge body at the distal end. The head assembly surface of the cartridge (2) can be in contact with the cartridge cap retaining ribs (CC9) (not shown in Figure 23). This secures the cartridge (2) inside the cartridge cap (1). The septum of the cartridge may allow needle penetration to access fluid (6) for delivery. It also seals the fluid (6) in the cartridge (2) at the distal end. A rubber plunger at the proximal end of the cartridge (2) is adaptable to seal the body of the fluid (6) at the proximal end. A cartridge volume scale (CC7) (not shown in Figure 23) may be provided on the cartridge cap (1 ) from distal to proximal. The cartridge body (CC8) of the cartridge cap (1) protects the cartridge or bottle (2) from damage caused by accidental drop situations. A cartridge retaining rib (CC9) (not shown in FIG. 23 ) provided on the distal end of the cartridge cap (1 ) can contact the cartridge head surface to retain the cartridge.

The fluid delivery pen dose setting/indexing mechanism may include a dose dial coil (DDT), clutch tube (CT), ratchet cap (50) and finger pad (TP). The dose dial coil (DDT) and clutch tube (CT) are located concentrically between the inner body (IB) and the outer body (OB). A ratchet cap (50) may be positioned between the clutch tube (CT) and the dose dial coil (DDT) towards the proximal ends of the clutch tube (CT) and the dose dial coil (DDT). A finger pad (TP) may be located on the proximal end of ratchet cap (50).

Referring to Figures 2, 3 and 23, the clutch tube (CT) may have two diametrically opposed one-way ratchets (CT1) at the proximal end against the one-way ratchet of the ratchet cap (50). The ratchet teeth (52) function to provide a click during indexing of the dose. The clutch tube (CT) has at its distal end two diametrically opposed clutch springs (CT2) against a circumferentially inner rib (DDT9) positioned towards the distal portion of the dose dial coil (DDT). ) function to disengage the dog tooth (DDT8) distal to the dose dial knob undercut (DDT7) of the dose dial coil (DDT) during scale setting/dose setting. Four longitudinal channels (CT4) run partly from distal to proximal on the inner surface of the clutch tube (CT), the distal ends of the four longitudinal channels (CT4) perform as the four most scaled stops (CT3). A hard stop function. The four longitudinal channels (CT4) of the clutch tube (CT) and the four drive lugs (DSK4) on the drive shaft keyway (DSK) are positioned so that the drive lugs (DSK4) can travel along the clutch tube channels (CT4) in Linear motion moves. Four longitudinal channels (CT4) perform two functions of the fluid delivery pen. First, it provides telescoping linear motion to the drive shaft keyway lug (DSK4) during dial up or down dose indexing. Second, it can transfer rotational actuation to the drive shaft keyway lug (DSK4) during dosing of fluid. Four dog teeth (CT5) at 90° relative to each other may be disposed distal to the clutch tube (CT) drive shoulder on the clutch tube (CT) outer surface. During fluid dosing, the dog tooth (CT5) of the clutch tube (CT) may engage the dose dial coil dog tooth (DDT8) of the dose dial coil (DDT) to engage the dosing mechanism. A circular drive shoulder (CT6) may be located distal to the one-way ratchet teeth (CT1) and proximal to the dog teeth (CT5) of the clutch tube (CT). Drive shoulder (CT6) may carry input force from ratchet cap (50) drive shoulder (RC4) to engage the clutch mechanism during dose activation.

Referring to Figures 2, 3 and 23, a functional description of the dose dial coil (DDT) can be described as follows. The proximal portion of the dose dial tube (DDT) includes the dose dial knob (DDT3), dose dial handle (DDT2), dose dial knob undercut (DDT7), dog teeth (DDT8), and ratchet teeth (DDT10). The dose dial coil (DDT) may be cylindrical and its proximal end may be referred to as the dose dial knob (DDT3), the dose dial knob (DDT3) being larger than the dose scale The distal side of the distal portion of the disc knob (DDT3) has a larger diameter. A zero stop notch (DDT1) may be provided on the outer surface of the distal end of the dose dial coil (DDT). The zero stop notch (DDT1) may be a small rectangle cut out of the dose dial coil (DDT). This can act as a rotational stop against the outer body zero stop (OB3) on the inner surface of the outer body (OB), where the outer body zero stop (OB3) originates longitudinally in the proximal direction at the distal end of the inner rib wall (OB7) And terminate at the nearest circumferential helical rib (OB4). The dose dial handle (DDT2) is set on the outer surface of the dose dial knob (DDT3) of the dose dial coil (DDT) and leads from the proximal end of the dose dial knob (DDT3) to the distal end linear ribs. The dose dial handle (DDT2) may facilitate easier control of the dose dial knob (DDT3) during dose indexing. The dose dial knob (DDT3) may be the proximal portion of the dose dial coil (DDT), having a larger diameter than the smaller diameter distal portion. A helical channel (DDT4) may be provided on the outer surface of the dose dial coil (DDT), the threaded channel (DDT4) may interact with the helical rib (OB4) of the outer body (OB) to form a cooperating threaded relationship. The last dose click ratchet (DDT5) placed diagonally opposite the zero stop notch (DDT1) at the distal end of the dose dial coil (DDT) is in contact with the last dose click on the inner surface of the outer body (OB) The rib (OB2) cooperates to create a click when the pen returns to zero scale, as shown in Figure 21, Section G-G of Figure 16. A dose dial (DDT6) may be disposed circumferentially on the outer surface of the dose dial coil (DDT) and may indicate the number of dialed units of fluid to be delivered. Dosage scales may range from 0 to 60 units or greater in steps of 1 unit. The circular dose dial knob undercut (DDT7) may be located distal to the ratchet teeth (DDT10) and proximal to the dog teeth (DDT8) on the inner surface of the dose dial coil (DDT). The dose dial knob undercut (DDT7) performs two functions. First, it keeps the ratchet cap (50) inside the dose dial coil (DDT) head. Second, it provides linear clearance for dogtooth (DDT8) clutches. Clutch action may include decoupling during indexing/dose setting or engaging during dose delivery. A dog tooth (DDT8) circumferentially disposed on the inner surface distal to the dose dial knob undercut (DDT7) engages with the clutch tube (CT) dog tooth (CT5) after the finger pad (TP) is depressed, Resulting in engagement of the dosing mechanism. A circular inner rib (DDT9) may be provided on the inner surface proximal to the distal end of the dose dial coil (DDT) and may act against the clutch spring (CT2) to disengage the dog teeth during indexing/dose setting ( DDT8). Ratchet teeth (DDT10) may be disposed circumferentially on the inner surface of the dose dial knob (DDT3) of the dose dial coil (DDT), may extend from its proximal end to its distal end and terminate at the dose dial knob Proximal end of undercut (DDT7). The ratchet teeth (DDT10) of the dose dial coil (DDT) can act against the ratchet cap (50) one-way ratchet (51) to provide a click during indexing up/dose setting (Fig. 17, Fig. 16 Section C-C shown). Up indexing/dose setting may indicate that the dose is set in an incremental manner. Each tooth of the ratchet teeth (DDT10) may correspond to a single dose increase shown on the dose dial coil scale.

The finger pad (TP) may be part of the dose setting/injection assembly and may be present at the proximal end of the injection device. Referring to Figures 2, 3, 27 and 28, the Finger Pad (TP) feature can be described as follows. The finger pad (TP) may be cylindrical and may have a cylindrical pivot pin (TP2) of varying diameter protruding distally from the proximal inner surface at the center of the finger pad (TP). The proximal end of the pivot pin (TP2) may have a larger diameter at the distal end, wherein the distal end may have a smaller diameter within the constraints of the size of the ratchet member of the fluid delivery pen. Three teeth (TP1) protrude laterally at 120° to each other on the inner peripheral surface of the finger pad (TP). The distal end of the outer surface of the pivot pin (TP2) may form a running surface (TP3). The proximal end of the finger pad (TP) may form a dose button (TP4). The peripheral surfaces of the larger and smaller diameter pins can form rotational bearings (TP5; TP5a; TP5b).

The ratchet cap (50) may be part of the dose setting/injection assembly. The ratchet cap (50) is shown in Figures 15, 17, 18, 25, 26 and 28, respectively. Ratchet cap (50) may be considered to have a distal portion and a proximal portion. The proximal and distal portions of ratchet cap (50) may be integrally molded or may be joined by other standard attachment means. The ratchet cap (50) serves as a component during operation of the fluid delivery pen. The distal end of the distal portion of the ratchet cap (50) may have a larger diameter than the proximal end of the distal portion of the ratchet cap (50). The proximal portion of the ratchet cap (50) may include retaining ribs (RC6), running surfaces (56), shaft holes (54), and rotational bearings (58, 59). Referring to FIG. 28, three retaining ribs (RC6) (numbers not shown in FIG. 28) may be provided at the proximal end of the proximal portion of the ratchet cap (50) at 120° to each other. A distal interior surface of the proximal portion of ratchet cap (50), which may extend partially into the distal portion of ratchet cap (50), may form a running surface (56). The inner circular proximal and distal surfaces of ratchet cap (50) may act as rotational bearings (58, 59).

The distal portion of ratchet cap (50) may include one-way ratchet teeth (52), one-way ratchet (51 ), drive surface (RC4) and outer rib (RC5). The distal portion of the ratchet cap (50) may be cylindrical/circular, its distal end may have a circular external rib (RC5), and its distal face may form a drive surface (RC4). External ribs (RC5) may facilitate retention of the ratchet cap (50) within the dose dial coil (DDT) head. The outer rib (RC5) may have two diametrically opposed one-way ratchets (51 ) proximally. The one-way ratchet (51) may be formed by a central diametrical cut on the outer surface of the ratchet cap (50). Proximal to the outer rib (RC5) in the distal portion of the ratchet cap (50), one-way ratchet teeth (52) are disposed circumferentially on the inner surface of the ratchet cap (50). A circular opening extending from the proximal end of the proximal portion of the ratchet cap (50) to the running surface (56) of the proximal portion of the ratchet cap (50) forms a shaft bore (54).

Referring to Figures 17-18 and Figures 25-28, the working mechanism between the finger pad (TP) and the ratchet cap (50) during operation of the fluid delivery pen may be as follows. The finger pad (TP) lateral assembly can be retained to the ratchet cap (50) by snapping the finger pad clip teeth (TP1) to the ratchet cap (50) retaining rib (RC6). Also, the finger pad (TP) pivot pin (TP2) can be aligned with the ratchet cap (50) pivot hole (RC3). The cooperation between finger pad (TP) rotating support (TP5) and ratchet cap (50) shaft hole (RC3) can provide lateral stability between finger pad (TP) shaft pin (TP2) and finger pad (TP) and ratchet cap Reduced friction between (50). The running surface (TP3) of the finger pad (TP) can cooperate with the running surface (56) of the ratchet cap (50). The user can apply force to the dose button (TP4), which force can be transmitted from the finger pad (TP) running surface (TP3) through the finger pad (TP) pivot pin (TP2) to the running surface (56) of the ratchet cap (50). User input force can also be transferred through the drive surface (RC4), causing engagement of a dog clutch mechanism comprising a clutch tube (CT) dog (CT5) and a dose dial tube (DDT) dog (DDT8) to activate dose delivery. The rotation support (58,59) of the ratchet cap (50) and the rotation support surface (TP5, TP5a, TP5b) of the finger pad cooperate to provide the finger pad (TP) pivot pin (TP2) and the ratchet cap (50) shaft hole ( 54) between lateral stability.

Referring to Figures 2, 3 and 23, the working mechanism between the ratchet cap (50), clutch tube (CT) and dose dial coil (DDT) of the fluid delivery pen may be as follows. The helical orientation of the helical channel (DDT4) on the outer surface of the dose dial coil (DDT) is right handed, the helical rib (OB4) on the inner surface of the outer body (OB) is oriented left handed and vice versa . During upward dose indexing/dose setting, the dose dial coil can follow the helical channel (DDT4) on the dose dial coil (DDT) and the helical ribs (OB4) on the inner surface of the outer body (OB) The helical orientation rotates either clockwise or counterclockwise. If the orientation of the helical channel (DDT4) on the dose dial coil (DDT) can be left handed, the dose dial coil can rotate in a clockwise direction during upward dose indexing/dose setting. If the orientation of the helical channel (DDT4) on the dose dial coil (DDT) can be right handed, the dose dial coil can rotate in a counterclockwise direction during upward dose indexing/dose setting. During dose up/dose setting, the one-way ratchet (51 ) of the ratchet cap (50) can act against the dose dial coil (DDT) ratchet teeth (DDT10), creating a click. During indexing down/dose setting, the clutch tube (CT) one-way ratchet (CT1) can act against the one-way ratchet teeth (52) of the ratchet cap (50) to provide a click (as shown in Figure 18, Fig. 16 as shown in the section). Since the size of the one-way ratchet (51) of the ratchet cap (50) can be larger than the size of the one-way ratchet (CT1) of the clutch tube (CT), the ratchet tooth (DDT10) for the dose dial tube (DDT) The upward indexing/dose setting when activated produces a more audible click than the downward indexing/dose setting click when activated against the one-way ratchet teeth (50) of the ratchet cap (50). The driving surface (RC4) of the ratchet cap (50) can carry the input force, because the surface of the driving surface (RC4) and the driving shoulder (RC6) are in direct contact with each other, the input force can pass from the finger pad (TP) through the running surface of the ratchet cap (50) (56) is passed to the clutch tube (CT) drive shoulder (CT6). This input force can engage the clutch tube (CT) dog (CT6) with the dose dial coil (DDT) dog (DDT8), resulting in engagement of the dosing mechanism during fluid delivery. Once the fluid (6) can be fully administered, the ratchet dial coil (DDT) internal rib (DDT9) during the next up or down indexing/dose setting for subsequent fluid (6) administration The clutch tube spring (CT9) can be acted upon to disengage the dog teeth (DDT8) to facilitate the achievement of the desired dose setting. Engagement of clutch tube (CT) dog (CT6) with dose dial tube (DDT) dog (DDT8) and indexing/dose setting up or down during dose delivery through finger pad (TP) force transmission Periodic disengagement of the clutch tube (CT) dog (CT6) from the dose dial coil (DDT) dog (DDT8) can be critical to the operation of the fluid delivery pen.

The exterior of the fluid delivery pen may include a pen cap (PC) and an outer body (OB). The pen cap (PC) can encapsulate a medicine bottle or a perfusion device (2). The outer body (OB) may house the dose setting/indexing and dose drive mechanisms. Shock resistance of these components can be critical to protecting mechanisms and fluid contents. The cap (PC) and outer body (OB) can be held by the user during use. The pen cap (PC) can be removed to allow fitting of the needle (4) and injection of the dose, and refitted to protect it from contamination. The outer body (OB) can be held for dose setting and dose injection. The overall product aesthetics can also be heavily determined by the shape of these external parts, including the colored core at the end of the pen cap (PC) and the pocket clip (PC2).

The desired dose index selection can be entered by the user by turning the dose dial coil knob (DDT3). Tactile feedback can be given via up or down ratchet teeth (51, CT1) formed in ratchet cap (50) and clutch tube (CT), respectively. Each ratchet can act against an array of teeth (DDT10, 52), wherein each tooth in the array of teeth can represent a single dosage unit. During indexing or dose setting, the dose dial coil (DDT) is free to rotate relative to the stationary clutch tube (CT) with the aid of a spring loaded dog clutch mechanism. The maximum dose setting is determined by a longitudinally extending channel (CT4) within the clutch tube (CT). As the dose dial coil (DDT) can be rotationally indexed, the clutch tube (CT) can follow the outer lug (DSK4) of the drive shaft keyway (DSK) (as shown in Figure 18, Section D-D of Figure 16) Travel telescopically. At maximum travel, the drive shaft keyway lug (DSK4) may contact the end of the clutch tube channel (CT4) and prevent further indexing or dose setting.

To deliver the selected dose, the user may apply force to the finger pad (TP). This force can be transferred to the clutch tube (CT) through the ratchet cap (50), locking the clutch tube (CT) to the dose dial coil (DDT). Therefore, as the dose dial coil (DDT) can rotate, the clutch tube (CT) can also rotate until the dose dial coil (DDT) can stop at the outer body (OB) zero scale stop (OB3).

During dose delivery, the rotational action of the clutch tube (CT) can be related to the drive shaft keyway (DSK) via diametrically opposed lugs (DSK4). The drive shaft keyway (DSK) can then be rotated over the one-way ratchet (IB4) on the inner body (IB). The one-way ratchet (IB4) can interact with the drive shaft spline (DSK1) to prevent reverse rotation of the mechanism due to compression of the fluid in the cartridge, as shown in Fig. 19, section E-E of Fig. 16 . The rotation can be transferred to the drive shaft (31) via the square/rectangular hole (DSK3) on the drive shaft keyway (DSK), where the square/rectangular hole (DSK3) can fit a similar square/rectangular head on the drive shaft (31). A helical rib (36) may run along the length of the drive shaft (31), wherein the helical rib (36) may act within a helical channel (37) on the hollow piston rod (30) to form a drive thread. This thread converts the rotational actuation of the dosing mechanism into a linear displacement of the hollow piston rod (30). The hollow piston rod (30) head/flange (PR2) can then act against the syringe plunger (10) to expel fluid from the syringe (2) or vial. Two diametrically opposite lugs (PR1) on the hollow piston rod (30) run along channels (IB7) on the inner body (IB) preventing rotation of the hollow piston rod (30) during dosing, as shown in Fig. 20. As shown in the section F-F of Fig. 16. The hollow piston rod (30) lug (PR1) can contact the end of the inner body (IB) anti-rotation channel (IB7), locking the pen mechanism from further delivery. This may serve as an indicator to the user that the last dose has been delivered.

The fixation of the cartridge (2) in the cartridge cover (1) and the fixation of the cartridge cover (1) in the pen assembly can be studied with reference to Figure 2, Figure 3 and Figure 23. The cartridge (2) or bottle can be fitted inside the cartridge cap (1). The cartridge (2) may be axially aligned by a series of ribs (CC5) which may extend longitudinally within the cartridge cover (1). The head (7) and neck (8) of the cartridge (2) may be located in the head and neck region of the cartridge cap (1). A helical thread (CC1) may be located at the distal end of the cartridge cap (1 ) to allow threaded assembly of the needle. The cartridge cap (1) may be secured within the pen assembly by an external circular rib (CC4) which engages with a circular channel (OB5) on the inner surface at the distal end of the outer body (OB). )Cooperate. A series of ribs (OB1) distributed around the inner surface of the outer body (OB) may facilitate axial alignment. Two diametrically opposed viewing windows (CC3) extend along the length of the cartridge cover (1). These may allow the user to visually identify the amount of fluid remaining in the cartridge (2) or bottle. The two card protrusions can also be placed diametrically opposite for linear clamping and rotational orientation (CC2) of the assembled pen cap (PC).

the term

OB outer body outer body

OB1 Alignment Rib Outer Body

OB2 Last Dose Click Rib Outer Body

OB3 Zero Stop Rib Outer Body

OB4 spiral rib outer body

OB5 round card slot outer body

OB6 dose dial window outer body

OB7 Inner ribs Outer body

OB8 Anti-rotation rib Outer body

PC Pen Cap Pen Cap

PC1 Orientation Feature Cap

PC2 Pen Cap Clip Pen Cap

PC3 Pen cap refill Pen cap

PC4 Alignment Rib Cap

PC5 round card slot Cap

CT Clutch Tube Clutch Tube

CT1 one-way ratchet clutch tube

CT2 clutch spring clutch tube

CT3 Max Scale Stop Clutch Tube

CT4 Longitudinal channel Clutch tube

CT5 dog tooth clutch tube

CT6 Drive Shoulder Clutch Tube

DDT dose dial coil dose dial coil

DDT1 Zero Stop Notch Dose Dial Coil

DDT2 Dose dial handle Dose dial coil

DDT3 Dose Dial Knob Dose Dial Coil

DDT4 Spiral Channel Dose Dial Coil

DDT5 Last dose click ratchet Dose dial coil

DDT6 Dose Scale Dose Scale Coil

DDT7 Dose Dial Knob Undercut Dose Dial Coil

DDT8 Dog Tooth Dose Dial Coil

DDT9 Internal Rib Dose Dial Coil

DDT10 Ratchet Teeth Dose Dial Coil

TP finger pad finger pad

TP1 Teeth Finger Pad

TP2 Pivot Pin Finger Pad

TP3 Running Surface Finger Pad

TP4 dose button finger pad

TP5 (TP5a, TP5b) Swivel Bearing Finger Pad

IB inner body inner body

IB1 bearing surface inner body

IB2 Anti-rotation notch Inner body

IB3 directional teeth inner body

IB4 one-way ratchet inner body

IB5 Last dose stopped Internal body

IB6 bayonet inner body

IB7 anti-rotation channel inner body

IB8 bayonet channel inner body

Body in IB9 datum plane

DSK drive shaft keyway drive shaft keyway

DSK1 Drive hole Drive shaft keyway

DSK2 Clip Finger Drive Shaft Keyway

DSK3 drive hole drive shaft keyway

DSK4 Drive Lug Drive Shaft Keyway

DSK5 Swivel Bearing Drive Shaft Keyway

1 Filler cap Filler cap

CC1 Thread Filler Cap

CC2 Rotation Orientation Filler Cap

CC3 Viewing window Filler cover

CC4 Retaining Rib Filler Cap

CC5 Alignment Rib Filler Cap

CC6 Orientation notch Filler cap

CC7 Filler Volume Scale Filler Cap

CC8 Filler Body Filler Cap

CC9 cartridge retention ribs cartridge cover

11 Helical threads on outer surface Filler cap

9 Neck area Filler cap

30 Hollow piston rod Hollow piston rod

PR1 Anti-rotation lug Hollow piston rod

PR2 Piston Flange Hollow Piston Rod

PR3 Blocking Surface Hollow Piston Rod

37 Helical thread Drive shaft

31 Drive shaft Drive shaft

36 Helical Rib Drive Shaft

DS2 drive head drive shaft

DS3 chuck drive shaft

31’ Shoulder Bearing Drive Shaft

50 ratchet cap ratchet cap

52 One-way ratchet teeth Ratchet cap

51 One-way ratchet Ratchet cap

54 Shaft hole Ratchet cap

RC4 drive face ratchet cap

RC5 External Rib Ratchet Cap

RC6 Retaining Rib Ratchet Cap

56 Running surface Ratchet cap

58,59 Swivel bearing Ratchet cap

2 Filler Filler Assembly

6 Fluid Guanliu steam components

10 Rubber plunger Filler assembly

7 head cartridge assembly

8 Neck Filler Assembly

3-pin header Needle assembly

4 pin pin assembly

5 Needle cover Needle assembly

Claims (65)

1. a fluid delivery pen, including: (i) perfusion device lid (1)；(ii) cap for brush (PC)；(iii) the interior main body of arranged concentric And outer main body (OB) (IB)；Described perfusion device lid (1) includes the perfusion device (2) comprising fluid (6)；Described interior main body (IB) includes Drive mechanism；Described drive mechanism includes hollow piston rod (30), is used for making drive shaft (31) and drive shaft keyways (DSK) rotate At least one driving means；Described hollow piston rod (30) has the screw (37) being positioned on inner surface；Described driving Axle (31) has the spiral ribs (36) being positioned on outer surface；The screw (37) of described piston rod (30) and described drive shaft (31) spiral ribs (36) coordinates, and is formed threaded and is axially retained along proximal direction relative to described outer main body (OB)； Described fluid delivery pen also includes dosing mechanism；Described dosing mechanism includes (i) dose dial dish of arranged concentric Pipe (DDT)；(ii) clutch tube (CT) and (iii) thumb pad (TP)；Described clutch tube (CT) is positioned at described dose dial coil pipe (DDT) in；Described dose dial coil pipe (DDT) and described clutch tube (CT) are positioned at described main body (IB) and described outer main body (OB) between；Described fluid delivery pen is characterised by, described dosing mechanism also includes ratchet cap (50)；Described ratchet cap (50) unidirectional ratchet (51) and single direction ratchet tooth (52) are included；Described unidirectional ratchet (51) and described single direction ratchet tooth (52) to Produce the click of higher audibility during upper dosage setting and during downward dosage setting, produce the click of relatively low audibility.

Fluid delivery pen the most according to claim 1, wherein said ratchet cap (50) be positioned at described clutch tube (CT) with Between described dose dial coil pipe (DDT), towards described clutch tube (CT) and the near-end of described dose dial coil pipe (DDT) and It is positioned at the nearside of thumb pad (TP).

Fluid delivery pen the most according to claim 2, wherein said holding rib (RC6) is positioned at the near of described ratchet cap (50) The near-end of sidepiece.

Fluid delivery pen the most according to claim 2, the inner circular near-end table of the proximal portion of wherein said ratchet cap (50) Face and rounded distal surface are formed and rotationally support (58,59).

Fluid delivery pen the most according to claim 2, wherein from the proximal extension of the proximal portion of described ratchet cap (50) extremely The circular open of the far-end of the proximal portion of described ratchet cap (50) forms axis hole (54).

Fluid delivery pen the most according to claim 5, the distal inner surface shape of the proximal portion of wherein said ratchet cap (50) Become running surface (56).

Fluid delivery pen the most according to claim 2, the far-end of the extremity of wherein said ratchet cap (50) is formed and drives Face (RC4).

Fluid delivery pen the most according to claim 7, the drive surface (RC4) of wherein said ratchet cap (50) and described clutch Driving shoulder (CT6) of device pipe (CT) coordinates.

Fluid delivery pen the most according to claim 8, the external rib (RC5) of wherein said ratchet cap (50) be positioned at described in drive The nearside in dynamic face (RC4).

Fluid delivery pen the most according to claim 9, the external rib (RC5) of wherein said ratchet cap (50) and described dose Amount scale coil pipe (DDT) dose dial spiral button undercutting (DDT7) coordinate.

11. fluid delivery pens according to claim 10, wherein Dens Canitis (DDT8) is arranged on described dose dial coil pipe (DDT) be positioned at dose dial spiral button undercutting (DDT7) nearside inner surface on.

12. fluid delivery pens according to claim 9, wherein single direction ratchet tooth (52) is arranged on described ratchet cap (50) Externally-located rib (RC5) nearside inner surface on.

13. fluid delivery pens according to claim 12, wherein unidirectional ratchet (51) arranges ratchet cap (50) described in pin It is positioned on the outer surface of single direction ratchet tooth (52) nearside.

14. fluid delivery pens according to claim 13, wherein unidirectional ratchet (51) be arranged on described dose dial dish Hook tooth (DDT10) on the inner surface of pipe (DDT) coordinates.

15. fluid delivery pens according to claim 12, the single direction ratchet tooth (52) of wherein said ratchet cap (50) with set Put the unidirectional ratchet (CT1) on the near-end of described clutch tube (CT) to coordinate.

16. fluid delivery pens according to claim 11, the Dens Canitis (DDT8) of wherein said dose dial coil pipe (DDT) with The Dens Canitis (CT5) of described clutch tube (CT) coordinates.

17. fluid delivery pens according to claim 16, wherein clutch tube (CT) have driving shoulder (CT6), described in drive Dynamic shoulder (CT6) is positioned at distally and the nearside of described Dens Canitis (CT5) of unidirectional ratchet (CT1).

18. fluid delivery pens according to claim 17, wherein clutch spring (CT2) is positioned at described clutch tube (CT) Far-end.

19. fluid delivery pens according to claim 18, clutch spring (CT2) pin of wherein said clutch tube (CT) The internal rib (DDT9) of described dose dial coil pipe (DDT) is worked.

20. fluid delivery pens according to claim 19, wherein said clutch tube (CT) longitudinal channels (CT4) is described The inner surface of clutch tube (CT) proximally leads to far-end, and the far-end of described longitudinal channels forms maximum scale and stops (CT3).

21. fluid delivery pens according to claim 1, wherein final dose click ratchet (DDT5) is arranged on described dosage The far-end of the outer surface of scale coil pipe (DDT).

22. fluid delivery pens according to claim 21, the final dose click of wherein said dose dial coil pipe (DDT) Ratchet (DDT5) coordinates with final dose click rib (OB2) of described outer main body (OB).

23. fluid delivery pens according to claim 22, wherein zero stopping rib (OB3) is arranged on described outer main body (OB) The inner surface towards far-end on.

24. fluid delivery pens according to claim 23, in the distal surface of wherein said dose dial coil pipe (DDT) Zero stops recess (DDT1) coordinates with zero stopping rib (OB3) of described outer main body (OB).

25. fluid delivery pens according to claim 24, wherein spiral ribs (OB4) is arranged on described outer main body (OB) On inner surface.

26. fluid delivery pens according to claim 25, are provided with the outer surface described dose dial coil pipe (DDT) On spiral channel (DDT4) coordinate with the spiral ribs (OB4) on the inner surface being arranged on described outer main body (OB).

27. delivery pens according to claim 2, the cylindrical pivot pin (TP2) of wherein said thumb pad (TP) is arranged on described At the inner proximal surface at thumb pad (TP) center.

28. delivery pens according to claim 27, it is described that the near-end of the pivot pin (TP2) of wherein said thumb pad (TP) has ratio The diameter that far-end is big.

29. delivery pens according to claim 28, the clip tooth (TP1) of wherein said thumb pad (TP) is arranged on described thumb pad (TP) in inner peripheral surface.

30. fluid delivery pens according to claim 29, the far-end of the outer surface of wherein said thumb pad (TP) forms operating Surface (TP3).

31. fluid delivery pens according to claim 30, the proximally and distally formation of wherein said pivot pin (TP2) rotates props up Hold (TP5a, TP5b).

32. fluid delivery pens according to claim 29, the clip tooth (TP1) of wherein said thumb pad (TP) and described ratchet cap (50) holding rib (RC6) coordinates.

33. fluid delivery pens according to claim 27, the wherein cylindrical pivot pin (TP2) of thumb pad (TP) and ratchet cap (50) Axis hole (54) alignment.

34. fluid delivery pens according to claim 30, wherein thumb pad (TP) operating face (TP3) and the fortune of ratchet cap (50) Turn face (56) to coordinate.

35. fluid delivery pens according to claim 31, the rotationally supporting of wherein said thumb pad (50) (TP5a, TP5b) with Rotationally support (58,59) of described ratchet cap (50) coordinate.

36. fluid delivery pens according to claim 1, wherein said circular internal-rib wall (OB7) is arranged on described outer master The distal inner surface of body (OB).

37. fluid delivery pens according to claim 36, the internal-rib wall (OB7) of wherein said outer main body (OB) is interior with described Datum level (IB9) contact of main body (IB).

38. according to the fluid delivery pen described in claim 37, and wherein latch (IB6) is positioned at the datum level of described main body (IB) (IB9) nearside.

39. according to the fluid delivery pen described in claim 37, and the internal-rib wall (OB7) of wherein said outer main body (OB) is interior with described The latch (IB6) of main body (IB) is relative.

40. are arranged along described internal-rib wall (OB7) side according to the fluid delivery pen described in claim 39, the most anti-rotation rib (OB8) On the inner surface of described outer main body (OB).

41. fluid delivery pens according to claim 40, the anti-rotation rib (OB8) of wherein said outer main body (OB) is interior with described The anti-rotation recess (IB2) of main body (IB) coordinates.

42. fluid delivery pens according to claim 1, wherein take on supporting (31 ') and are positioned at the nearside of described drive shaft (31) The far-end in portion.

43. fluid delivery pens according to claim 42, wherein drive shaft keyways (DSK) is positioned at described drive shaft (31) Near-end.

44. fluid delivery pens according to claim 43, wherein driving head (DS2) is positioned at the nearside of shoulder supporting (31 ').

45. fluid delivery pens according to claim 44, the nearside table of shoulder supporting (31 ') of wherein said drive shaft (31) Face coordinates with the supporting surface (IB1) of described interior main body (IB).

46. fluid delivery pens according to claim 44, driving head (DS2) surface of wherein said drive shaft (31) and institute State complementary drive hole (DSK3) surface engagement of drive shaft keyways (DSK).

47. fluid delivery pens according to claim 44, wherein card chuck (DS3) is positioned at the near of described driving head (DS2) Side and the near-end of described drive shaft (31).

48. fluid delivery pens according to claim 47, wherein card chuck (DS3) and described drive shaft keyways (DSK) Drive shaft keyways folder (DSK2) coordinates.

49. fluid delivery pens according to claim 43, wherein said drive shaft keyways (DSK) tooth array (DSK1) is positioned at The extremity of described drive shaft keyways (DSK).

50. fluid delivery pens according to claim 43, wherein said drive shaft keyways (DSK) tooth array (DSK1) and institute The unidirectional ratchet (IB4) stating interior main body (IB) interacts.

51. fluid delivery pens according to claim 43, wherein drive lug (DSK4) to be positioned at described drive shaft keyways (DSK) in proximal cylindrical part.

52. fluid delivery pens according to claim 51, the driving lug (DSK4) of wherein said drive shaft keyways (DSK) Coordinate with the longitudinal channels (CT4) of described clutch tube (CT).

53. fluid delivery pens according to claim 1, the wherein said cap for brush (PC) extremity includes three alignment rib (PC4), described three alignment rib (PC4) be arranged on the described cap for brush (PC) from the inner surface of far-end to near-end.

54. fluid delivery pens according to claim 53, the wherein said cap for brush (PC) proximal portion includes (i) alignment features (PC1)；(ii) circular card conduit (PC5).

55. fluid delivery pens according to claim 54, wherein said alignment features (PC1) and described perfusion device lid (1) Spin orientation (CC2) alignment.

56. fluid delivery pens according to claim 55, wherein said circular card conduit (PC5) and described perfusion device lid (1) engaging.

57. fluid delivery pens according to claim 1, also include final dose mechanism, are positioned at hollow piston rod including (i) (30) the anti-rotation lug (PR1) on and block surface (PR3)；(ii) the anti-spin slot road (IB7) being positioned in described main body (IB) (IB5) is stopped, in preventing the coordinating of wherein said block surface (PR3) and described final dose stopping (IB5) with final dose The linear displacement of empty piston rod (30), indicates the end of fluid (6) in described perfusion device (2).

58. fluid delivery pens according to claim 57, wherein unidirectional ratchet (IB4) is arranged on described interior main body (IB) Near-end.

59. fluid delivery pens according to claim 58, the unidirectional ratchet on the near-end of wherein said interior main body (IB) (IB4) distally is circular bearing surfaces (IB1).

60. fluid delivery pens according to claim 59, the most anti-rotation recess (IB2) is arranged on described interior main body (IB) On far-end.

61. fluid delivery pens according to claim 60, wherein datum level (IB9) is positioned at the anti-rotation of described main body (IB) The distally of recess (IB2).

62. fluid delivery pens according to claim 61, wherein final dose stops (IB5) towards described interior main body (IB) The far-end of outer surface be positioned at the nearside of described datum level (IB9).

63. fluid delivery pens according to claim 57, the most anti-spin slot road (IB7) is led to from the near-end of described interior main body Far-end.

64. fluid delivery pens according to claim 57, the most anti-rotation lug (PR1) is arranged on described hollow piston rod (30) on proximally facing outer surface.

65. fluid delivery pens according to claim 57, wherein block surface (PR3) and are arranged on described hollow piston rod (30) on outer surface.